| CTRI Number |
CTRI/2021/03/031731 [Registered on: 05/03/2021] Trial Registered Prospectively |
| Last Modified On: |
20/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
NEW TECHNIQUE OF REGIONAL ANALGESIA TO REDUCE PAIN AFTER BREAST SURGERY |
|
Scientific Title of Study
|
THE EFFICACY OF ERECTOR SPINAE PLANE BLOCK IN MODIFIED RADICAL MASTECTOMY FOR POST OPERATIVE ANALGESIA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRAWAN SONI |
| Designation |
POST GRADUATE TRAINEE, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
NIL RATAN SIRCAR MEDICAL COLLEGE HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
138 ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
DEPARTMENT OF ANAESTHESIOLOGY
138 ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
PIN 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
7980091937 |
| Fax |
|
| Email |
shrawu.soni89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARCHANA ROY |
| Designation |
ASSISTANT PROFESSOR, DEPARTMENT OF ANAESTHESIOLOGY |
| Affiliation |
NIL RATAN SIRCAR MEDICAL COLLEGE HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
138 ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
DEPARTMENT OF ANAESTHESIOLOGY
138 ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
PIN 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9830278254 |
| Fax |
|
| Email |
roy.archana23@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
SHRAWAN SONI |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
NIL RATAN SIRCAR MEDICAL COLLEGE HOSPITAL |
| Address |
NRS MEDICAL COLLEGE
DEPARTMENT OF ANAESTHESIOLOGY
138 ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
DEPARTMENT OF ANAESTHESIOLOGY
138 ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
PIN 700004
Kolkata
WEST BENGAL
700004
India |
| Phone |
9830278254 |
| Fax |
|
| Email |
shrawu.soni89@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIL RATAN SIRCAR MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
NIL RATAN SIRCAR MEDICAL COLLEGE |
| Address |
138, ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
PIN 700004
WEST BENGAL |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHRAWAN SONI |
NIL RATAN SIRCAR MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY
138, ACHARYA JAGADISH CHANDRA BOSE ROAD
KOLKATA
PIN 700004
Kolkata
WEST BENGAL |
7980091937
shrawu.soni89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NRS MEDICAL COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERECTOR SPINAE PLANE BLOCK |
ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK GIVEN AT T3 VERTEBRAL LEVEL USING LOCAL ANAESTHETIC ROPIVACAINE 0.2% CONCENTRATION . |
| Comparator Agent |
GENERAL ANAESTHESIA |
GENERAL ANAESTHESIA GIVEN WITH ENDOTRACHEAL INTUBATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
FEMALE PATIENTS WITH CARCINOMA OF BREAST POSTED FOR MODIFIED RADICAL MASTECTOMY OPERATION |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
ASA PHYSICAL STATUS 3 OR MORE
BODY MASS INDEX MORE THAN 35
LOCAL SITE INFECTION
DRUG ALLERGY
BLEEDING DISORDER
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF POST OPERATIVE ANALGESIA |
0, 1/2, 2, 4, 6, 8, 12 , 24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TOTAL OPIOID REQUIREMENT FOR POST OPERATIVE ANALGESIA |
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/03/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK WILL BE GIVEN AT T3 VERTEBRAL LEVEL USING 30 ML OF LOCAL ANAESTHETIC ROPIVACAINE 0.2 % BEFORE GENERAL ANAESTHESIA . POST OPERATIVE ANALGESIC EFFICACY WILL BE COMPARED WITH ONLY GENERAL ANAESTHESIA PATIENTS GROUP. |